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Last Updated: January 27, 2023

Acalabrutinib - Generic Drug Details


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What are the generic sources for acalabrutinib and what is the scope of patent protection?

Acalabrutinib is the generic ingredient in one branded drug marketed by Astrazeneca and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acalabrutinib has one hundred and fifty-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for acalabrutinib
Recent Clinical Trials for acalabrutinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Kite, A Gilead CompanyEarly Phase 1
Acerta Pharma, LLCEarly Phase 1
Jeremy Abramson, MDPhase 2

See all acalabrutinib clinical trials

Pharmacology for acalabrutinib
Drug ClassKinase Inhibitor
Mechanism of Action Tyrosine Kinase Inhibitors
Paragraph IV (Patent) Challenges for ACALABRUTINIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CALQUENCE Capsules acalabrutinib 100 mg 210259 5 2021-11-01

US Patents and Regulatory Information for acalabrutinib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca CALQUENCE acalabrutinib maleate TABLET;ORAL 216387-001 Aug 3, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca CALQUENCE acalabrutinib maleate TABLET;ORAL 216387-001 Aug 3, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca CALQUENCE acalabrutinib maleate TABLET;ORAL 216387-001 Aug 3, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for acalabrutinib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AstraZeneca AB Calquence acalabrutinib EMEA/H/C/005299
Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Authorised no no no 2020-11-05
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for acalabrutinib

Country Patent Number Title Estimated Expiration
Japan 2007509060 See Plans and Pricing
Serbia 58177 4-IMIDAZOPIRIDAZIN-1-IL-BENZAMIDI I 4-IMIDAZOTRIAZIN-1-IL-BENZAMIDI KAO INHIBITORI BTK (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK-INHIBITORS) See Plans and Pricing
South Korea 101802689 See Plans and Pricing
Japan 2018035184 BTK阻害剤としての4−イミダゾピリダジン−1−イル−ベンズアミドおよび4−イミダゾトリアジン−1−イル−ベンズアミド (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK INHIBITORS) See Plans and Pricing
Norway 2021016 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for acalabrutinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2734522 21C1014 France See Plans and Pricing RODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522 2021C/512 Belgium See Plans and Pricing PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
2734522 PA2021004 Lithuania See Plans and Pricing PRODUCT NAME: AKALABRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105
2734522 2021016 Norway See Plans and Pricing PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111
2734522 LUC00202 Luxembourg See Plans and Pricing PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Johnson and Johnson
Baxter
Moodys
AstraZeneca

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